Effectiveness and Safety of a Clinical Assessment and 0h/1h Troponin Rule-Out Protocol

NCT03421873 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16000

Last updated 2019-09-11

No results posted yet for this study

Summary

Chest pain is a common presenting complaint at the Emergency Department (ED). Many of these patients undergo lengthy assessments in the ED or are admitted which contributes to ED and hospital crowding as well as a substantial health care burden. The now commonly used high-sensitivity cardiac troponin assays enable faster rule-out of acute myocardial infarction (AMI). The European Society of Cardiology (ESC) recommend the use of a 0h/1h high-sensitivity cardiac troponin T (hs-cTnT) protocol, but all studies so far have been observational. The safety and effectiveness of the protocol when implemented in routine care is thus unknown.

The aim of this study is to determine the safety and effectiveness of the ESC 0h/1h hs-cTnT protocol, supplemented with clinical assessment and ECG, when implemented in routine care.

Conditions

Interventions

OTHER

0h/1h hs-cTnT protocol

Implementation of a 0h/1h hs-cTnT protocol in routine care

Sponsors & Collaborators

  • Region Skane

    collaborator OTHER
  • Lund University

    collaborator OTHER
  • Ulf Ekelund

    lead OTHER

Principal Investigators

  • Arash Mokhtari, MD, PhD · Lund University, Skåne University Hospital, Department of Internal and Emergency Medicine, Department of Cardiology, Lund, Sweden

  • Ulf Ekelund, MD, PhD · Lund University, Skåne University Hospital, Department of Internal and Emergency Medicine, Lund, Sweden

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2018-12-30
Completion
2018-12-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03421873 on ClinicalTrials.gov